NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Pneumococcal respiratory tract infections
Date of first enrollment	27/03/2009
Target sample size	150
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : DU-6859a (sitafloxacin hydrate) INN of investigational material : sitafloxacin Therapeutic category code : 624 Synthetic antibacterials Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Safety, bacteriological efficacy, and PK-PD
Secondary Outcome	Clinical efficacy

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients with age of 20 or older at the time of obtaining informed consents. 2) Patients who provided proper sputum for cultivation of pathogenic bacteria. 3) Patients who is suspected to be pneumococcal infection with at least one of below**: (1) Neutrophils and Gram-positive diplococci can be seen in Gram stained smears of airway secreta (sputum etc.). (2) Urinary antigen detection test for S. pneumoniae is positive. ** (1) is essential for the patients received antibacterial drug within 7 days (14 days for azithromycin) from the start of therapy. 4) Patients who diagnosed as a mild or moderate infectious disease according to the guideline (Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy) on the day or the day before the start of therapy and fit for oral antibacterial drug therapy.
Exclude criteria	1) Patients with a history of allergy/severe adverse effect to quinolone antibacterial agents. 2) Patients with a history of seizure/epilepsy or patients who are taking antiepilepsy drug. 3) Pregnant or breastfeeding patients, or patients who have the possibility of being pregnant. 4) Patients with severe hepatic impairment, renal impairment, and cardiac impairment. 5) Patients who have difficulty in judgment of the efficacy of the study drug (including patients suffering from cancer or other underlying diseases which prevent the evaluation). 6) Patients required ICU care or mechanical ventilator. 7) Patients with gastrointestinal disorders which affect the drug absorption. 8) Patients required prohibited concomitant medications or treatments in this study. 9) Patients who initiated long-term macrolide therapy or corticosteroid administration (systemic or inhalation), or changed the dosage of them within fourteen days prior to the test drug. 10) Patients received sitafloxacin or azithromycin within seven days prior to the test drug. 11) Patients who attended any other clinical trial within 60 days prior to this trial. 12) Other patients judged to be inappropriate by the attending physician.